Cervical Cytology DNA Methylation for Endometrial Cancer Screening

NCT07874529 | Active Not Recruiting

• 1 other identifier: K9733
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to conduct the "Real-world Study on Cervical Cytology Methylation Testing for Endometrial Cancer Screening" project through a multi-center real-world research approach. Led by Peking Union Medical College Hospital, at least 10 institutions will participate in the study. The goal is to complete the enrollment of at least 30 million real-world samples. Focusing on the changes in DNA methylation levels in cervical exfoliated cells as the research entry point, this study aims to provide new ideas and theoretical basis for preventing and treating endometrial cancer by targeting the CDO1/CELF4 double gene methylation. The expectation is to achieve the clinical application of a more optimal endometrial cancer screening protocol, improve the current shortcomings of endometrial cancer screening, make endometrial cancer screening more accurate, effectively reduce the incidence of endometrial cancer, and avoid excessive medical treatment.

Conditions

Endometrial Cancer; DNA Methylation; Cytology; Cancer Screening

Outcome Measures

Primary Outcomes (1)

• Number of participants with histopathological diagnosis of endometrial cancer

  1 year

Interventions

CDO1 and CELF4 gene methylation DIAGNOSTIC_TEST

CDO1m and CELF4m for cervical cancer screening

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All women asking for Collection of cervical exfoliated cells in hospital situation or in community situation

You may qualify if:

• Age is 18 years old or above.
• Agree to undergo the routine methylation test for endometrial cancer and participate in the study;
• The medical records are complete and include the results of endometrial tissue pathology examination.
• Be informed of the relevant risks of the project and voluntarily sign the informed consent form.

You may not qualify if:

• Cancer of the female reproductive system under treatment (except for endometrial cancer);
• Active bleeding from the lower genital tract;
• Immunosuppressed state (such as after HIV infection, organ transplantation, etc.)

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 8, 2026
• First Posted: October 15, 2026
• Study Start: December 12, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)